Description
I am currently in charge of finding the new Sr. Manager of GCP for a mid-sized pharmaceutical company in the San Jose area. This company currently has over 20 on-going clinical trials and will be going commercial with their oncology drug by 2014. I have spoke directly with the hiring manager and I know that the most important thing for a candidate to posses is passion because they are racing against time to save lives. The best candidates should also posses the follwing experience.- Minimum of 8 to 10+ years' experience in the pharmaceutical/biotechnology industry
- Minimum of 7+ years' auditing in one of the following areas: GCP, GLP, GPvP
- Expert knowledge of technical concepts required for all aspects of GCP Auditing, to include all types of GCP audits; e.g., Study Sites, Vendors, essential study documentation
- Solid understanding of domestic and international pharmaceutical/Biotechnology auditing standards
- Extensive experience supporting regulatory authority inspections of clinical research activities
- Hands-on experience managing quality and compliance projects and programs
- Proven ability in driving quality process improvement initiatives.
- Extensive leadership experience and mentoring skills Thorough knowledge and application of international requirements of Good Clinical Practice (GCP) and ICH Guidelines
To find out more about Real please visit www.realstaffing.com